Label: PREMIUM HAND SANITIZER- ethanol gel
- NDC Code(s): 68599-5201-1, 68599-5201-2, 68599-5201-3, 68599-5201-4
- Packager: MCKESSON MEDICAL-SURGICAL INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 25, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PREMIUM HAND SANITIZER
ethanol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68599-5201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) TOCOPHEROL (UNII: R0ZB2556P8) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) ISOPROPYL ALCOHOL (UNII: ND2M416302) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68599-5201-1 118 g in 1 PACKAGE; Type 0: Not a Combination Product 01/09/2015 2 NDC:68599-5201-2 237 g in 1 PACKAGE; Type 0: Not a Combination Product 01/09/2015 3 NDC:68599-5201-3 532 g in 1 PACKAGE; Type 0: Not a Combination Product 01/09/2015 4 NDC:68599-5201-4 1000 g in 1 PACKAGE; Type 0: Not a Combination Product 01/09/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/09/2015 Labeler - MCKESSON MEDICAL-SURGICAL INC. (023904428) Establishment Name Address ID/FEI Business Operations Central Solutions 007118524 manufacture(68599-5201)